Status:
TERMINATED
Study of Efficacy on Cardiac Remodeling of Recombinant Human Neuregulin-1 in Stable Chronic Systolic Heart Failure Patients
Lead Sponsor:
Zensun Sci. & Tech. Co., Ltd.
Conditions:
Chronic Systolic Heart Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a multi-center, randomized, double-blind , placebo parallel controlled, standard therapy based phase III clinical trial, to evaluate the efficacy of recombinant human neuregulin-1 on cardiac r...
Detailed Description
RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it.Both the preclinical trial and phase II clinical trail have confirmed t...
Eligibility Criteria
Inclusion
- Age between 18 and 75, both sex.
- Left ventricular ejection fraction (LVEF)≤40% (ECHO).
- NYNA functional class II\~III.
- Definitely diagnosed with chronic systolic heart failure (including medical records, symptoms and physical signs)and clinical symptom is steadily in the latest 1 month.
- Receiving standard basic treatment of heart failure, has reached the objective dosage or the highest tolerated dosage for at least 1 month, or the dosage has not been changed for at least 1 month.
- Capable of signing the informed consent form.
Exclusion
- Patients with atrial fibrillation.
- Patients with a pacemaker.
- Patient with a metallic implant.
- Patient with Claustrophobia.
- Patients with acute myocardial infarction, Hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
- Ischemic heart failure without recanalization or with recanalization in recent six months.
- Cardiac surgery or cerebrovascular accident within recent six months.
- Preparing for heart transplantation or has received CRT treatment.
- Serious hepatic or renal dysfunction caused by organic pathological changes (Cr\>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
- Patients need mechanical ventilation.
- Systolic blood pressure \<90mmHg or \>160mmHg.
- Patients with acute hemodynamic disorder or decompensation in the last 1 month.
- Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
- Serum potassium \<3.2 mmol/L or \>5.5 mmol/L.
- Pregnant or plan to pregnant.
- Unmarried or married but not procreated women at child-bearing age.
- Subject with a life expectancy less than 6 months as assessed by the investigator.
- Patients who participated in any clinical trial in the recent three months.
- History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
- Evidence (physical examination,CXR,ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism.
- Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01439893
Start Date
June 1 2011
End Date
June 1 2012
Last Update
December 21 2017
Active Locations (4)
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1
Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
Beijing, Beijing Municipality, China
2
Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
Beijing, Beijing Municipality, China
3
Cardiovascular Institute and Fuwai Hospital
Beijing, Beijing Municipality, China
4
General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China